Cessatech announces last participant dosed in pivotal trial 0205 with lead candidate CT001
- Last participant has been randomised in clinical trial 0205 investigating efficacy and safety of CT001 relative to placebo and two comparative active arms
- Primary aim is to show that CT001 offers a better pain reduction and safety profile compared to the comparative arms and placebo
- Top-line results are anticipated during Q4 2023 once data has been analysed
Copenhagen, Denmark, 21 September - Cessatech A/S ("Cessatech" or "the Company") announces that the last participant has been randomized in clinical trial 0205, investigating the postoperative analgesic efficacy of CT001 in adults, following impacted mandibular third molar extraction, a randomised, double-blind placebo-controlled trial with 220 participants.
The trial is part of the Paediatric Investigation Plan (PIP) for CT001 nasal spray that has been agreed by the European Medicines Agency. The trial is conducted in adults as it is considered unethical to perform placebo-controlled pain trials in children. The previous trials 0201, 0204, and 0206 will be combined in a final modelling and simulation study to evaluate the dose response profile for CT001. The last clinical safety study 0202 is expected to be initiated later this year.
Jes Trygved, CEO, Cessatech
We are very pleased that we have now reached the important milestone with recruitment of the last participant in trial 0205. This trial is the biggest so far in Cessatech's history with 220 adults recruited and the clinical team, dental clinics and site have really worked hard to reach this important milestone. We are grateful to both the team and the adults that participated in this trial. We now wait with excitement for the next step, the remaining follow up visits and then data will get cleaned and results analysed. We expect to have top-line results during Q4.